Ultimovacs (ULTI) småprat 1

[h3nk1]

Hehe, mens vi andre romsterte om portis og stresset som **** for å få deltatt på emisjonen på 125 som kom med NSCLC og r2p #5.

Sausen derimot hadde mer is i magen og plukker under emikurs

[Christian]

Carlos de Sousa and closely related parties hold 14,056 shares and
416,035 share options in Ultimovacs ASA.

Aksjer for rundt 50 mill?

Dagens kjøp er jo bare for å si at kursen er på bærtur

[h3nk1]

Det er ikke første gangen.

[Otard]

Innsidekjøpet er vel direkte følge av lønning og julegratiale samt lav kurs å gjøre det på.

Teorien om lockup falt imidlertid.

[polygon]

Vanskelig dette med innsidekjøp: Damned if you do, damned if you don’t

[Otard]

Det er utelukkende positivt i mine øyne om uttalelsen min kan leses på noen annen måte.

Mener bare at de fleste ikke har 114 000 liggende å slenge og nå har julebonusen antagelig kommet, derfor passet det bra å handle litt på cybermandag.

[h3nk1]

Tipper det kommer nye kjøp i dag

[Fornybar]

[h3nk1]

Siden notering har aksjen vært to korte turer under MA100: midt i det verste koronakrakket våren 2020, samt et par uker på vårparten i år da KLP og FIL-Limited bokstavelig salt synkronraserte aksjen med nedsalg over børs.

Innen seks måneder er hovedstudien (INITIUM) ferdig rekruttert og man har fått mer informasjon om TET-plattformen. Oppdaterte data fra UV1 pluss pembro (80 % (!) OS) kommer samtidig.

I tillegg kommer ukjente, men sannsynlige VIPs.

Med et perspektiv på 6 - 12 måneder forventer jeg derfor kurser som er ~100 prosent høyere enn i dag. En ting er at det er attraktivt å handle under emisjonskurs. Å attpåtil kunne kjøpe nærmere MA100 tilsier god R/R.

[h3nk1]

Notorisk vanskelig å treffe bunn i markedet. Selskap med finanser, eiere og rekruttering på stell er om ikke annet litt mer skjermet om det skulle bli full storm.

Må bare vedgå at jeg ikke så en så kraftig nedside etter emisjonen. Som følge av kursfallet er det passende at man er tilnærmet all-inn igjen, nøyaktig ett år siden sist.

[TekBot]

Ultimovacs ASA: Mandatory notification of trade by primary insider

Oslo, 2 December 2021, Carlos de Sousa, Chief Executive Officer and primary
insider in Ultimovacs ASA, has today bought 1,000 shares in the company at a
price of NOK 107.60 per share. Following this transaction, Carlos de Sousa and
…

Vis børsmeldingen

closely related parties hold 15,056 shares and 416,035 share options in
Ultimovacs ASA.

This information is subject to the disclosure requirements pursuant to the
Market Abuse Regulation article 19 and section 5-12 of the Norwegian Securities
Trading Act.

Kilde

[Fornybar]

De Sousa sin måte å fortelle markedet på at 2022, det skjer.

[Christian]

Liker at det meldes samme dag

[TekBot]

Ultimovacs Granted Orphan Drug Designation by FDA for UV1 Cancer Vaccine in Metastatic Melanoma

• Designation covers UV1 in Metastatic Melanoma as sole agent or part of
  combination
  • Seven-year market exclusivity after regulatory approval, if received
    …

Vis børsmeldingen

Oslo, 2 December 2021: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical
stage leader in immune stimulatory vaccines for cancer, today announces that the
U.S. Food and Drug Administration (FDA) has granted orphan drug designation
(ODD) for the company’s universal cancer vaccine UV1 for the treatment of stage
IIB - IV melanoma. UV1, as add-on therapy to checkpoint inhibitors ipilimumab
and nivolumab, is currently being studied as first-line treatment for metastatic
melanoma in a Phase II trial named INITIUM.

The FDA Office of Orphan Products Development (OOPD) supports and advances the
development and evaluation of new treatments for rare diseases that affect fewer
than 200,000 people in the U.S. Orphan drug designation provides certain
benefits, including seven-year market exclusivity upon regulatory approval if
received, exemption from FDA application fees and tax credits for qualified
clinical trials.

In October this year, the U.S. FDA granted Fast Track designation to UV1 as add-
on therapy to ipilimumab or to pembrolizumab for the treatment of unresectable
or metastatic melanoma.

“We are very pleased to have been granted this orphan drug designation for UV1
in treating metastatic melanoma. The designation underlines the promise of UV1
that has been shown in our clinical studies in metastatic melanoma to date,”
said Carlos de Sousa, CEO of Ultimovacs. “We remain committed to further
investigating UV1 in our ongoing Phase II clinical studies and to continuing our
constructive dialog with regulators to bring UV1 to patients as soon as
possible.”

UV1 is being investigated in combination with checkpoint inhibitors in Phase II
trials covering advanced malignant melanoma, ovarian cancer, head and neck
squamous cell carcinoma, malignant pleural mesothelioma, and non-small cell lung
cancer (NSCLC). In total, the five Phase II trials will enroll more than 650
patients at nearly 100 clinical centers across 15 countries.

                                ==ENDS==

About Ultimovacs
Ultimovacs is developing immune-stimulatory vaccines to treat a broad range of
cancers. Ultimovacs’ lead universal cancer vaccine candidate UV1 targets human
telomerase (hTERT), present in 85-90% of cancers in all stages of tumor growth.
By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells
to the tumor to activate an immune system cascade and increase anti-tumor
responses. With a broad Phase II program, Ultimovacs aims to clinically
demonstrate UV1’s impact in multiple cancer types in combination with other
immunotherapies. Ultimovacs’ second technology approach, based on the
proprietary Tetanus-Epitope-Targeting (TET) platform, combines tumor-specific
peptides and adjuvant in the same molecule and entered Phase I studies in 2021.

About Melanoma
Melanoma is the fifth most common cancer in both men and women in the U.S., with
more than 100,000 new cases of melanoma diagnosed every year. Ultimovacs’
INITIUM clinical trial uses UV1 in combination with checkpoint inhibitors
ipilimumab and nivolumab to treat metastatic melanoma (Stage III - IV melanoma),
including the later stages of the disease in which the melanoma has spread to
lymph nodes and/or to more distant parts of the body. In addition to surgery or
radiation therapy, checkpoint inhibitors have become standard of care treatment
for metastatic melanoma. The 5-year survival rate for patients with Stage IV
metastatic melanoma is approximately 20-30%.

For further information, please see www.ultimovacs.com or contact:

Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632

Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
Phone: +44 7483 284 853

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Joachim Midttun, Finance
Manager at Ultimovacs ASA, on December 2, 2021 at 19:00 CET.

Kilde

[Fornybar]

Orphan Drug Designation Awardees are Granted the Following Benefits from the FDA:

• Tax credits of 50% off the clinical drug testing cost awarded upon approval
• Eligibility for market exclusivity for 7 years post approval
• Waiver of new drug application (NDA)/ biologics license application (BLA) application fee (approximately $2.2 million value) (more details)

[Fornybar]

fornybar

Lik og retweet for å få den åpenbare casen mer synlig.

[Fartin]

Er det noen som har god oversikt på nye konkurrenter som kombinerer med cpi? Det er vel en indikasjon der satses mye på. Er det fase 1/2 fase 2 studier som kan true uv1 resultatmessig?

30% cr hadde vel uv1 med pembro. Mot 6% cr pembro alene.
Men hva med andre utfordrere i denne indikasjonen? Initium studien jeg tenker på her.

[Boms]

Du blander vel metastatic og malignt melanom. Malignt melanom er nok en så stor indikasjon at du ikke får orphan dryg designation på den.

Men for all del en bullish melding.

[Fornybar]

Inclusion Criteria:

Male or female patients at least 18 years of age at the time of signing the ICF.
Histologically confirmed diagnosis of unresectable stage IIIB D, or unresectable stage IV malignant melanoma.
Eligible for combination treatment with nivolumab and ipilimumab.

[busk1]

Da er den vel orphan bare for Stage IV?